Recall MonitorHealth Products
Bard SILASTIC® Foley Catheter
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Bard SILASTIC® Foley Catheter
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33416 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33420 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33620 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33622 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33418 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33422 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33616 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33614 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33618 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33424 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33624 |
Issue
BD has received complaints, and confirmed through internal inspection that stains are present on the surface of the affected SILASTIC® catheters. The cause of the stains was determined to be an increased amount of a raw material used in the manufacturing process. This raw material may be harmful if present in increased amounts on the surface of the catheter.